Device and method for correcting spinal deformities in patients

ABSTRACT

Devices and related methods for the dynamic correction of spinal deformities are disclosed. The devices and methods are particularly useful for correcting an abnormal curvature of the spine. In one exemplary embodiment, a method for correcting deformity via a spinal implant that can include a polymer between or attached to a top and bottom plate, which can exist in a wedge-shaped configuration in order to apply asymmetric forces to the spinal column, is provided. The implant may be inserted between adjacent vertebrae comprising part of the abnormal curvature, thereby restoring the normal curvature of a spine.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of and relies on thedisclosures of and claims priority to U.S. patent application Ser. No.16/535,007, filed Aug. 7, 2019, which relies on the disclosures of andclaims priority to and the benefit of the filing date of U.S.Provisional Patent Application No. 62/715,638, filed Aug. 7, 2018. Thedisclosures of those applications are hereby incorporated by referenceherein in their entireties.

BACKGROUND Field of the Invention

The present invention relates to methods and devices for correctingspinal deformities in humans and animals.

Spinal deformity, which typically includes transverse, lateral, and/orrotational misalignment of the vertebrae, can consist of variousdeformities, such as the following: kyphosis (exaggerated forwardcurvature of the upper spine), osteochondrosis (abnormal growth of thethoracic spine), scoliosis (abnormal curvature usually most notable inthe coronal plane, but also including sagittal and rotationalmisalignment), and spondylolisthesis (displacement of lumbar vertebrae).Other factors resulting in spinal deformity may include, but are notlimited to, fractures due to trauma and spondylitis. Techniques forcorrecting such deformities can be loosely divided into two categories,external and internal. External devices, such as braces, limit themobility of the patient and are uncomfortable, resulting in low usercompliance. Brace technology has therefore been inadequate to correctdeformity and may prevent progression and in some cases induce worsenedcurvature.

Internal techniques for correcting deformity include the fusion ofadjacent vertebrae through the immobilization of one or more vertebralelement(s) and the distraction of the intervertebral disc space. In mostcases, interbody cages and/or bone grafts are placed within the discspace to space the vertebrae and align them in an orientation thatpromotes fusion while also restoring the previous or desired angularrelationship to achieve correct curvature of the spine. While many ofthese techniques are effective, fusion has negative effects on the rangeof motion of the patient and may, in cases, cause complications;sometimes severe complications. Furthermore, correction of deformitiesoften requires fusion at multiple levels. Lastly, fusion on one levelhas so far been ineffective in correcting multilevel spinal deformity.

Thus, there exists a need for improved methods and devices forcorrecting spinal deformities while preserving motion capability andpromoting user compliance.

Description of Related Art

U.S. Pat. Nos. 6,045,579 and 6,080,193 describe an “Adjustable HeightFusion Device,” which comprises a method and apparatus for promotingspinal fusion between neighboring vertebrae. The apparatus is placedwithin the intervertebral space and preferably adapted to vary thedistance between the engaging plates such that the height of theapparatus proximate the anterior end is greater than the height at theproximate the posterior ends, whereby the natural lordosis of the spineis maintained after the apparatus is installed. An alternativepossibility describes the device containing struts with differentheights in order to treat scoliosis. The current invention may havediffering heights, but also contains an elastic section which appliesforces for correction and is not intended for use in fusion.

The suite of U.S. patents, including U.S. Pat. Nos. 6,436,102,6,447,548, 6,471,725, 6,562,047, 6,607,559, 6,740,119, 6,805,716,6,837,904, 6,863,689, 6,890,356, 7,153,310, 7,217,292, 7,507,255,7,550,008, 7,722,675, 8,038,717, 8,216,315, and 8,361,153, describemethods and implantation tools for a distraction method comprisingdistracting the space between vertebral bones by inserting a spacer,subsequently removing the spacer, and distracting with a wider spacer,all during one surgery. These spacers may be tapered, meaning the upperand lower surfaces are non-parallel such that the spacer comprises awedge shaped implant. Such a wedge-shaped implant may be used to treatscoliosis by returning proper alignment to vertebral bones. Unlike sucha technique covered by that suite of patents, the current invention isnot intended for use in fusion and is not a rigid element.

U.S. Pat. No. 6,682,564 consists of an implant where the body may have atapering height decreasing from the first end face to the second endface, and while also tapering more quickly in the first diagonaldirection. The angle between the tapered top and bottom faces may varydepending on where the device is implanted within the spine. The currentinvention, while it may be wedged, is not a rigid body and is notintended for use in fusion.

U.S. Pat. No. 7,780,733 is an artificial spinal disc implant method forintervertebral disc replacement in which upper and lower brackets arejoined together via springs connected to the upper bracket, which restin spring guide tracks on the lower bracket. The device is intended tosimulate the biological human disc. However, the current invention, in apreferred embodiment, uses springs to apply forces rather than absorbshock, which is unlike what is taught by the U.S. Pat. No. 7,780,733patent and much of the prior art.

U.S. Pat. No. 7,922,767 describes an implant which promotes disc fusionvia an inserted coil shaped device or devices. Such devices may beimplanted simultaneously with varying heights providing apost-implantation configuration that optimizes the relative positionbetween two vertebrae, thereby allowing for the treatment of scoliosis.The current invention, on the other hand, is not coil shaped andincludes elastic sections between endplates.

U.S. Pat. No. 8,097,037 describes a method for correcting a spinaldeformity comprising selecting two or more rigid body spinal implantsfrom a plurality of spinal implants, each implant having a wedge-shapedconfiguration. The current invention taught herein may be wedge shaped,but is not a rigid body, and is intended for use in applying asymmetricforces to the vertebral column, unlike the U.S. Pat. No. 8,097,037patented technology.

U.S. Pat. No. 8,118,873 describes an artificial vertebral joint forinterposition between a superior vertebra and an inferior vertebra,wherein the superior posterior element is configured to engage andarticulate with the inferior posterior element and a spacer extendingbetween the superior component and the inferior component, where thespacer may contain an internal mesh component with an elastic core. Thecurrent invention may have an elastic core, but, in embodiments,comprises multiple sections for applying asymmetric forces in additionto acting as a shock absorber.

U.S. Pat. No. 8,366,776 comprises a tapered vertebral implant for use inestablishing desired spinal curvatures including separate implantbodies. The bodies may include an associated angle between inferior andsuperior surfaces of the body and may be stacked so that the associatedangles are oriented in a different anatomical plane. Such orientationcould provide a rigid fixture for fusion in a preferred alignment. Thecurrent invention is not rigid as it contains an elastic section and isnot intended for fusion.

U.S. Pat. No. 8,377,138 is an intervertebral disc replacement device inwhich an artificial intervertebral disc is placed within the interbodyspace. The disc is made up of two parts, where the inner portion is thenuclear area and the outer portion is for structural support. The devicemay also include a coiled compression spring in the internal disc toprovide support; additionally, endplates can be positioned in a wedgeshape. The current invention contains an outer portion which is designednot to mimic the annulus of the disc and act in compression, but toactually apply forces to the adjacent vertebrae through extension of acompressed material to realign the vertebrae rather than merely providethe natural space and support between them.

U.S. Pat. No. 8,382,838 is an interbody vertebral replacement in whichan elastic center part surrounded by a fibre system is fit into thespace between adjacent vertebrae. The center part can be compressedaxially by loading in the vertebral column causing a bulge that isrestricted by the fibre system, thereby mimicking the in vivointervertebral disc. Unlike the current invention, the interbodyvertebral replacement is only designed to absorb shock. The currentinvention not only may absorb shock, but it also may contain multiplediscrete springs or polymer springs to apply forces to the adjacentvertebrae through extension of a compressed material to realign thevertebrae in addition to responding to the natural loading and movementof the spine.

U.S. Pat. No. 9,034,045 describes an expandable interbody implant devicefor separating two vertebrae and promoting fusion. The implant complainsramps so that lordosis may be matched. One side of the ramp can beshorter than another side of the ramp with a corresponding differencealong ramps. In this manner, a sideways orientation of the spine may becorrected. This device results in fusion of the vertebrae; it is alsoimportant to note most deformity is not merely a deformation in thecoronal plane. The current invention is not intended for fusion andadditionally corrects deformity in more than one plane.

In the above-mentioned patents, it is either claimed or hypothesizedthat scoliosis may be treated by expansion or applying forces in oneplane. However, scoliosis is not a single planar disease. Furthermore,implantation of a rigid, wedge shaped device or a device that may beconfigured into a wedged shape will result in the fusion of the adjacentvertebrae, which will A) likely not result the correction of scoliosisdue to an inability of the static forces to overcome the forces causingor linked to scoliosis, and B) result in the known presence of adjacentlevel disease, in which fusion at one level results in degeneration anddisequilibrial forces at the adjacent levels. It is noteworthy that adynamic system, such as that taught herein, will facilitate thecorrection of scoliosis without fusing the vertebrae.

SUMMARY OF THE INVENTION

The present invention is directed to specific devices and methodsintended for use in the correction of spinal deformity. In one exemplaryembodiment, a method for correcting spinal deformity comprises insertinga spinal implant into the disc space formed by adjacent vertebrae. Thedisc space may have a lateral side adjacent to the concave side ofcurvature along the vertical axis of the spine (the concave-lateralside) and a lateral side adjacent to the convex side of a curvaturealong the vertical axis of the spine (the convex-lateral side). Theconcave-lateral side may be of a lower height than the convex-lateralside due to the curvature of the spine. The method of treating spinaldeformity presented in this invention describes the use of asymmetricforces applied to the adjacent vertebrae to realign the vertebralsegment and have those forces thereby propagate through the spinalcolumn. The method uses the restoring force of the spring as defined byHooke's law. If an elastic material is compressed or expanded, therebybecoming displaced, it will exert a force such that it can be restoredto its initial position.

The spinal implant used to induce such forces may be comprised of a topand bottom face with a polymer spanning from the top face to the bottomface to be intraoperatively wedged and then inserted in said disc spaceso that the height of the implant is higher on the concave-lateral sideand lower on the convex-lateral side. The polymer may be elastic so thatthe implant desires to expand on the concave-lateral side and compresson the convex-lateral side, drawing the vertebrae into alignment. Thespinal implant can have a footprint that matches or resembles thefootprint of the endplates of the adjacent vertebrae, with ridges thatincrease the surface area between implant and vertebrae to allow forfrictional fixation. Forces exerted by the implant may propagate throughthe spinal column to align vertebrae adjacent to those directly adjacentto the implant.

In another embodiment, an implant is provided that may have a polymerregion where the polymer itself is preoperatively wedged so that it ishigher on the concave-lateral side and lower on the convex-lateral side.

In a further embodiment, an implant is provided that may have a regioninterior to the polymer—between the two faces and in some configurationswith the polymer—that has an elastic property that matches or resemblesthe elastic, shock absorbing properties of the previous disc. Theinterior region may be positioned in a cylindrical area more centralthan the polymer.

In yet another embodiment, a polymer, as provided, may be divided inmultiple sections, so that each section may have a differing height, oreach section may have a different elastic property so as to moreaccurately apply forces that may draw the vertebra into their properalignment.

In another embodiment, the implant described herein may have discretesprings organized around the interior elastic region, made of metal orpolymer, instead of solid polymer springs.

In another embodiment, the device may have spikes, bumps, or similarprotrusions that allow for surface matching that creates a frictionalinterface that promotes fixation of the top and bottom faces to theendplates of the adjacent vertebrae.

The present invention may also be attached to the endplates of adjacentvertebrae via a screw or other fixation system, in certain aspects,where one or more screws may be inserted through threads in either thetop or bottom face or both faces and into the endplate. The screws mayalso be inserted through a protrusion of the implant that existsparallel to a vertical face of an adjacent vertebrae.

The implant described may also exist in multiple sections that areinserted via routes on opposite or varying sides of the spine, havingfootprints matching or resembling the lateral half of the adjacentvertebral endplate. The implants may or may not connect to the oneanother via one or more mechanisms, including but not limited to adowel-to-hole connection, hooks, magnets, and/or screws.

The present invention also describes an implant which consists of afirst element which may be comprised of a top and bottom face with apolymer spanning from the top face to the bottom face. The element maybe connected via a hinge to a second element which may be comprised of atop and bottom face with a polymer spanning from the top face to thebottom face. The implant may be inserted so that the central axis of thefirst element is aligned with that of the second element and then thefirst element is rotated via a mechanism around the hinge so that it mayexist parallel to the second within the disc space.

In another embodiment, an implant is provided that may exist in asmaller version, so that two or more similar implants may be insertedvia opposite or varying sides of the spine and connected.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate certain aspects of embodiments ofthe present invention and should not be used to limit the invention.Together with the written description the drawings serve to explaincertain principles of the invention.

FIG. 1A depicts the spinal column in the coronal plane from theposterior view.

FIG. 1B depicts the lateral view of the spinal column in the sagittalplane.

FIG. 1C depicts an example case of spinal deformity in the coronalplane.

FIG. 1D depicts a vertebral segment from an isotropic view.

FIG. 1E depicts a vertebral segment from an anterior view.

FIG. 1F depicts a cross section of a typical vertebra.

FIG. 2A depicts an exemplary method for treatment of deformity usingasymmetrical forces from a coronal view.

FIG. 2B depicts the correction achieved using various wedged angleconstructs expanding upon this embodiment.

FIG. 2C depicts optimization of the corrective force.

FIG. 3A depicts an exemplary embodiment of the device from an isotropicview.

FIG. 3B depicts an exemplary embodiment from a side view.

FIG. 3C depicts an exemplary embodiment from a side view where thepolymer is preoperatively wedged.

FIG. 3D depicts a cross sectional view of an exemplary embodiment.

FIG. 3E depicts a cross sectional view from a vertical viewing plane ofan exemplary embodiment in which there exists an internal elasticregion, and a cross sectional view of an exemplary embodiment from ahorizontal viewing plane.

FIG. 3F depicts an example of an insertion of said embodiment into thevertebral column.

FIG. 4A depicts a cross sectional view of an exemplary embodiment wherethere exist multiple polymer sections.

FIG. 5A depicts a cross sectional view of an exemplary embodiment wherethere exist multiple discrete spring sections.

FIG. 5B depicts a side view of an exemplary embodiment where there existmultiple metal spring sections.

FIG. 6A-C depicts differing frictional surfaces taught herein.

FIG. 7A depicts a combination with screw implantation from a side view.

FIG. 7B depicts a combination with screw implantation from an anteriorview.

FIG. 8A depicts an embodiment where multiple device sections areinserted and may join from a top view.

FIG. 8B depicts a possible insertion of the multiple device sections.

FIG. 8C depict a possible connection mechanism of the multiple devicesections.

FIG. 9A depicts the hinge-mechanism embodiment from a top view.

FIG. 9B depicts the hinge-mechanism embodiment from a side view.

FIG. 9C depicts the hinge-mechanism embodiment from a top view withinthe vertebral space.

FIG. 10A depicts the multiple device hinge-mechanism embodiment from atop view.

FIG. 10B depicts the multiple device hinge-mechanism embodiment from atop view within the vertebral space.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS OF THE INVENTION

Various embodiments will now be described in detail to provide anunderstanding of the structure, function, manufacture, and use of thedevices and methods disclosed herein. It should be understood that thefollowing discussion of exemplary embodiments is not intended as alimitation on the invention; rather, the following discussion isprovided to give the reader a more detailed understanding of certainaspects and features of the invention.

One or more examples of the embodiments are illustrated in theaccompanying drawings. Those skilled in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Itwill be to those that various modifications and variations can be madein the practice of the present invention without departing from thescope or spirit of the invention; the features illustrated or describedin connection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention. Allreferences cited in this application are hereby incorporated byreference in their entireties.

The current invention describes methods and devices for correctingspinal deformities, and in particular, correcting abnormal curvatureincluding most cases of spinal deformity. In embodiments, one or moredynamic implants which exist in a wedge-shaped configuration or exertasymmetrical force to correct wedging are provided. In an exemplaryembodiment, one or more implants can be positioned between adjacentvertebra at the apex of curvature to increase the height of the discspace on the concave side and decrease that on the convex side bydynamically applying continuous forces to the endplates of the adjacentvertebrae over time.

Normal spinal orientation is depicted in FIG. 1A-B. In FIG. 1A, thespine is viewed posteriorly as it exists in the coronal plane (20) andin FIG. 1B, the spine is viewed laterally as it exists in the sagittalplane (22). The spine consists of 7 cervical vertebrae (10), 12 thoracicvertebrae (12), 5 lumbar vertebrae (14), the sacrum (16), and the coccyx(18). Spinal deformity typically occurs in some region between thethoracic and lumbar vertebrae. An example of spinal deformity,scoliosis, is shown in FIG. 1C in a posterior view as would be seen inthe coronal plane (24) with the apex of curvature located in thethoracic region (26). In FIG. 1D-E, a single vertebral segment is shown;the vertebral segment comprises a top and bottom vertebra as well as thedisc in between and the muscles and ligaments attached to the top andbottom vertebrae. In an embodiment, the current invention acts directlyon the vertebrae of a single vertebral segment, through which forces maypropagate to act on adjacent vertebral segments. A cross sectional viewof this vertebral segment is shown in FIG. 1F.

In one embodiment, the current invention comprises a method by which anexpansive force is applied to one or more concave aspects of thevertebral segment. A tensile force may also be applied to one or moreconvex aspects of the vertebral segment. Such forces increase disc spaceheight in concave aspects of the vertebral segment and decrease discheight in convex aspects of the vertebral segment. As shown in FIG. 2A,the forces may result in the realignment of the vertebral segment, whichmay lead to a propagation of forces through the spinal column,realigning other aspects of the column. In this method, a part of thedisc or the whole disc would be removed so as to insert an implant(2100) which could apply such forces. FIG. 2B depicts correctionachieved using various wedged angle constructs expanding upon thisembodiment. FIG. 2C presents data from a pilot study of forceoptimization in applying a corrective force to the spinal column fromwithin the disc space. Optimal correction curve was found to be withinthe range of 80 to 160 N, with maximum correction occurring at 120 N.Force above this range caused over correction, and those below causedundercorrection. Thus, the current method would involve the applicationof forces as described above and herein within a similarly optimizedrange.

In aspects, the implant, which may engage in such a method of correctionof deformity, may have various properties. One exemplary embodiment isshown in FIG. 3A-D, in which the device has a top plate (3200) andbottom plate (3300) with an elastic section in the middle (3400); thissection may be an elastic polymer. Such internal section, in a preferredaspect, is what applies the forces to the adjacent vertebra above andbelow the device. As shown in FIG. 3D, the cross-sectional area, inaspects, is of the same, similar, or approximate footprint, shape, orform as that of the vertebrae, so that it completely or partiallymatches the vertebral segment. The elastic section may have an internalregion (3500) which is less stiff and matches the elastic properties ofthe disc (e.g., FIG. 3E) to act as a shock absorber. The insertion ofsuch device (3100) into the disc space is shown in FIG. 3F; the device,in aspects, uses resultant forces to the wedging of the vertebrae thatpushed the concave aspects apart. According to data from a pilot studyof force optimization for such an elastic region in correcting ascoliotic curve, a factor of 200 was added to the force to account forthe normal axial loading of the spine. This value was derived based onresearch carried out by Izamburt et al., in which IVDs were preloadedwith 400 N of force to mimic axial loading of an adult spine. This valuewas halved to account for the lighter weight of the targeted pediatricpatient population. Required Young's modulus was determined to be 8.67MPa. The elastic modulus in a preferred embodiment of the currentinvention resembles that of the natural intervertebral disc, which lieswithin 5.8-42.7 MPa. This, however, may be a result of the small Cobbangle generated by current simulations. The required elastic modulus forthis material may be calculated in a similar manner to determinematerial characteristics of such an embodiment, and/or other embodimentspresented herein.

In one embodiment, the device may comprise multiple polymer sections(4600) in various shapes depending on what force(s) are desired to beapplied and where on the endplates of the adjacent vertebrae theforce(s) must or should be applied (see, e.g., FIG. 4A). Such a devicemay have shorter elements that pull one or more aspects of the vertebraetogether through a tensile force or longer elements that push aspects ofthe vertebrae apart, by way of example. Instead of polymer springs, thedevice may include discrete springs (5700) (see, e.g., FIG. 5A-B).

In order for the device to remain within the disc space, it ispreferable, in embodiments, to have as much of a contact with theadjacent vertebrae as possible to create a frictional interface betweenthe plates of the device and the endplates of the adjacent vertebrae. Avariety of interfaces can increase the surface area including ridges(see, e.g., FIG. 6A), spikes (see, e.g., FIG. 6B), bumps (see, e.g.,FIG. 6C), or other similar protrusions.

In order to apply a compressive force, it may be necessary to attach theimplant (7100) to the adjacent vertebrae via a screw, attachment, orsimilar, system (7800) (see, e.g., FIG. 7A-B). In embodiments, one ormore screws or other attachment mechanisms may be inserted through aprotrusion of one or both or more plates of the implant or through theone or both or more of the plates of the device itself.

The device may comprise a configuration in which it is divided into twoor more parts that make separate implants (8101 and 8102), or two ormore parts of the same implant. which can be inserted from two or moresides of the disc space (see, e.g., FIG. 8A-B). The device may exist astwo or more separate implants (or parts of the same implant) within thespace, or may be connected via one or more connecting mechanismsincluding, but not limited to, hooks or screws, by way of example only.(See, e.g., FIG. 8C).

Another possible embodiment of the device may require a smaller incisionto access the disc space. As shown in, for example, FIG. 9A-B, thedevice (9100) may, in aspects, have two or more elements with top andbottom plates with an elastic section in between that are connected viaa hinge mechanism (9900). The implant is inserted through an incisionand once placed in the disc space, the forward element of the device isrotated about the hinge so that it lies parallel to the back element(see, e.g., FIG. 9C).

Such hinged elements may be scaled to a larger size so the one or moredevices can be inserted into the disc space with one or more differentpolymer properties between the top and bottom plates. Such devices aredepicted in FIG. 10A-B. The devices can be inserted in variousorientations into the space as shown in FIG. 10B, particularly.

One skilled in the art will recognize that the disclosed features may beused singularly, in any combination, or omitted based on therequirements and specifications of a given application or design. Whenan embodiment refers to “comprising” certain features, it is to beunderstood that the embodiments can alternatively “consist of” or“consist essentially of” any one or more of the features. Otherembodiments of the invention will be apparent to those skilled in theart from consideration of the specification and practice of theinvention.

A “vertebral element” includes a vertebrae, a vertebrae disc, avertebrae above and below a disc, a space between vertebrae, a space invertebrae, a vertebrae endplate, and/or a portion of a spinal column,alone or together in any combination.

It is noted in particular that where a range of values is provided inthis specification, each value between the upper and lower limits ofthat range is also specifically disclosed. The upper and lower limits ofthese smaller ranges may independently be included or excluded in therange as well. The singular forms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is intendedthat the specification and examples be considered as exemplary in natureand that variations that do not depart from the essence of the inventionfall within the scope of the invention. Further, all of the referencescited in this disclosure are each individually incorporated by referenceherein in their entireties and as such are intended to provide anefficient way of supplementing the enabling disclosure of this inventionas well as provide background detailing the level of ordinary skill inthe art.

1. A spinal intervertebral disc implant device for alignment and/orrealignment of a spinal column in more than one plane or axis comprisingan elastic polymer component, wherein the spinal intervertebral discimplant device further comprises a top face and a bottom face, wherein aspace between the top face and the bottom face is capable of beingadjusted prior to or following insertion of the spinal intervertebraldisc implant device, and wherein the spinal intervertebral disc implantdevice is capable of: (a) absorbing shock; (b) applying asymmetricforce(s) to a vertebrae or vertebral element and adjacent vertebrae orvertebral element from within an intervertebral disc space by extensionand/or contraction of one or more portions of the elastic polymercomponent; (c) aligning and/or realigning a spinal column; and (d)responding to loading and/or movement of the spinal column.
 2. Thespinal intervertebral disc implant device of claim 1, wherein the spacebetween the top face and the bottom face is manually adjusted.
 3. Thespinal intervertebral disc implant device of claim 1, wherein the spacebetween the top face and the bottom face is adjustable by internal gearsand hinges that are capable of being manually adjustable by an externalmechanism, tool, or force.
 4. The spinal intervertebral disc implantdevice of claim 1, wherein the space between the top face and the bottomface is manually adjustable by expansion of a hinge in the device by anexternal mechanism, tool, or force.
 5. The spinal intervertebral discimplant device of claim 1, wherein the asymmetric force(s) are providedby: a. polymeric and metallic materials combined to form one or moresprings, solid bodies, or porous structures; or b. one or more metalsprings, solid bodies, or porous structures.
 6. A method of treatingspinal deformity comprising implanting an elastic device capable ofapplying asymmetric forces to adjacent vertebrae to realign a vertebrae,vertebral element, and/or spinal column, wherein the asymmetric forcespropagate through all or part of a spinal column in which the elasticdevice is implanted, wherein the elastic device comprises a rigid,multi-angled wedged device capable of applying the asymmetric forces bycontacting the adjacent vertebral elements, and wherein the devicecomprises an elastic metallic material.
 7. The spinal intervertebraldisc implant device of claim 1, wherein the spinal intervertebral discimplant device is inserted using a tool that creates a temporary bondwith the spinal intervertebral disc implant device.
 8. The method oftreating spinal deformity according to claim 6, wherein the elasticdevice is inserted using a tool that creates a temporary bond with theelastic device.
 9. The spinal intervertebral disc implant device ofclaim 1, wherein the spinal intervertebral disc implant device isinserted via an anterior plane.
 10. The spinal intervertebral discimplant device of claim 1, wherein the spinal intervertebral discimplant device is inserted via a lateral plane.
 11. The spinalintervertebral disc implant device of claim 1, wherein the spinalintervertebral disc implant device is inserted via a posteriolateralplane.
 12. The spinal intervertebral disc implant device of claim 1,wherein the spinal intervertebral disc implant device is inserted via atransforaminal plane.
 13. The method of treating spinal deformityaccording to claim 6, wherein the elastic device is inserted via ananterior plane.
 14. The method of treating spinal deformity according toclaim 6, wherein the elastic device is inserted via a lateral plane. 15.The method of treating spinal deformity according to claim 6, whereinthe elastic device is inserted via a posterolateral plane.
 16. Themethod of treating spinal deformity according to claim 6, wherein theelastic device is inserted via a transforaminal plane.